BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TALAR COMPONENT

    MDR report key: 22002628 · Received May 12, 2025

    Report

    Report Number
    1038671-2025-02029
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    January 25, 2024
    Report Date
    May 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    OYK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF BONE CYST FORMATION AS STATED IN THE REPORT, SUSPECTED PROSTHESIS WEAR, AND POSTERIOR MIGRATION OF THE TALAR COMPONENT. THE REPORTED PROSTHESIS COULD NOT BE CONFIRMED FROM THE AVAILABLE INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES OF THE EXPLANTED COMPONENTS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, AFTER IMPLANTATION OF A CEMENTLESS ANKLE JOINT ENDOPROSTHESIS, EXCESSIVE INLAY WEAR AND BONE CYSTS ON THE TIBIA AND TALUS WERE FOUND. THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS AND 7 MONTHS POST THE INITIAL SURGERY. ALL PARTS/PIECES WERE REMOVED FROM THE PATIENT. BASED ON X-RAYS PROVIDED, IT APPEARED THE TALAR COMPONENT HAD SUBSIDED/MIGRATED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812150 UNKNOWN TALAR COMPONENT ANKLE ARTHROPLASTY IMPLANTATION SYSTEM OYK EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization